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U.S. Department of Health and Human Services

Class 1 Device Recall Flowc Anesthesia System

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 Class 1 Device Recall Flowc Anesthesia Systemsee related information
Date Initiated by FirmMay 02, 2022
Date PostedJune 23, 2022
Recall Status1 Terminated 3 on August 06, 2024
Recall NumberZ-1278-2022
Recall Event ID 90250
510(K)NumberK191027 
Product Classification Gas-machine, anesthesia - Product Code BSZ
ProductFlow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Code Information UDI-DI: 07325710009765 Serial Numbers: 4003, 4777, 4783, 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078. (Note: UDI was corrected July 7, 2022)
Recalling Firm/
Manufacturer
Getinge Usa Sales Inc
1 Geoffrey Way
Wayne NJ 07470-2035
Manufacturer Reason
for Recall
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction unit from being activated.
FDA Determined
Cause 2
Component design/selection
ActionMaquet Critical Care AB/Getinge initiated a voluntary Medical Device Correction Letter on 5/2/22. . Examine your inventory immediately to determine if you have any of the Flow-c and/or Flow-e anesthesia system(s) with the serial numbers as listed in this notice. . You may continue use of the affected device ensuring that the recommended daily system check out (SCO) and pre-anesthesia checkout procedures are followed as listed in the Operators Manual. . Check for functionality of the suction unit. If you detect a cracked or broken on/off switch before starting a new case, the anesthesia machine should be replaced with a fully functioning anesthesia machine or you should ensure that a temporary alternative suction substitution is available. . Customers with affected system(s) will be contacted by a Getinge Service Representative to schedule on-site correction of your device. You can arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9GETUSA / (888) 943 8872 (select option 1, then option 2), Monday through Friday, between 8 am and 6 pm (Eastern Time Zone). Whether you have affected product or not, please complete and sign the attached MEDICAL DEVICE Correction - RESPONSE FORM to acknowledge receipt of this notification. Return the completed form to Getinge by e-mailing a scanned copy to actflow-ce.us@getinge.com or by faxing the form to (877) 548-4901. Action by the Getinge: Maquet Critical Care AB/Getinge has identified the cause of the issue. A solution that will correct this issue has been developed and your unit will be corrected at no cost to you by replacing the on/off switch with a new, more durable one.
Quantity in Commerce17 units US
DistributionUS Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri, and Virginia
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BSZ
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